Local Study Project Manager – Sponsor Dedicated

IQVIA

. Lead Local Study Teams at country level to deliver clinical study components according to resources, budget, timelines, procedural documents, ICH-GCP, and local regulations .

Posted 10/26/2026full-timeBratislava • SlovakiaSeniorLead💰 €41,600 - €62,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading clinical study teams and managing complex projects within the regulated clinical trial environment, with a strong focus on Oncology and Phase III studies. Proficient in regulatory compliance, financial management, and effective communication across diverse stakeholders.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory ComplianceOncology KnowledgePhase III Study ExperienceGCP and ICH Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory SubmissionStudy Financial ManagementTechnical WritingSite MonitoringDrug Development ProcessRisk AssessmentProject PlanningData ManagementFeasibility Assessment

Soft Skills

Negotiation SkillsInterpersonal SkillsTeam CollaborationCommunication SkillsProblem-Solving

Tools & Technologies

Regulatory SystemsTracking ToolsDatabase ManagementClinical Trial Management SystemsTMF Documentation

Industry Keywords

ICH-GCPLocal RegulationsClinical PracticeOncology TherapeuticsStudy ActivationStudy ClosureAudit ActivitiesRegulatory IntelligenceEssential Document ManagementSite Activation

About the role

Key responsibilities & impact

Lead Local Study Teams at country level to deliver clinical study components according to resources, budget, timelines, procedural documents, ICH-GCP, and local regulations
Ensure sites are identified, qualified, set up, initiated, monitored, closed, and archived
Oversee local regulatory and ethics submission packages, study submission milestones, regulatory activities, and study budget
Lead CRAs and Study Start Up Specialists and coordinate clinical and operational feasibility assessments
Coordinate site selection with relevant stakeholders
Plan and coordinate local drug activities from purchase or reimbursement through destruction
Set up and maintain studies in applicable systems and local websites
Oversee monitoring from site activation through study closure
Identify risks and facilitate resolution of complex study issues
Organize Local Study Team meetings and report study progress to the Global Study Associate Director/Global Study Team
Assist with forecasting timelines, resources, recruitment, budget, materials, and drug supplies
Ensure regulatory systems, payments, databases, tracking tools, timelines, project plans, and TMF documentation are accurate and maintained
Train and coach Local Study Team members
Plan and lead audit and regulatory inspection activities with Quality Assurance
Oversee Site Activation and Maintenance activities and collaboration across Regulatory and Start Up & Site Activation
Provide regulatory and technical scientific support
Determine regulatory strategy and submission authorization requirements
Assess regulatory landscape and contribute to regulatory intelligence
Maintain inspection-ready systems and timely essential-document uploads

Requirements

What you’ll need

Bachelor's Degree Life sciences or related field
7 years’ relevant experience in a scientific or clinical environment
Equivalent combination of education, training and experience
Knowledge of Oncology therapeutical area
Proven work experience in Phase III studies
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process, including site monitoring experience
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities
Very good knowledge of Slovak or Czech language and English language
Willingness to travel occasionally

Benefits

Comp & perks

Health and welfare benefits may be offered
Incentive plans, bonuses, and/or other forms of compensation may be offered